Ovary Syndrome for Efficient Diagnosis and Targeted Therapy

Polycystic Ovary Syndrome Clinical Trial

— PCOS-01  

Official title:

Understanding the Epigenetic Mechanisms in the Pathophysiology of Polycystic Ovary Syndrome for Efficient Diagnosis and Targeted Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06102629
• Other study ID #: PCOS-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 5, 2023
• Est. completion date: November 15, 2026

Study information

• Verified date: October 2023
• Source: Asian Institute of Gastroenterology, India
• Contact: Shraddha Ramchandani
• Phone: 9182645727
• Email: drshraddhamohan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

OBJECTIVES:

1. Analysis of DNA methyl transferases (DNMT1, DNMT3A and DNMT3B) and Histone deacetylases (HDAC 1,2,3 and SIRTs) polymorphisms (Somatic and germ line variations).

2. Analysis of differential mRNA and protein expression of epigenetic markers in ovarian tissues obtained from PCOS patients.

3. miRNA regulated epigenetic mechanisms in PCOS

4. Epigenetic regulation of endocrine genes in PCOS

DESIGN : A Case Control study.Sample size:200

Description:

1. We will take both blood and ovarian tissue samples used to diagnosis.

2. We will take approximately 3 ml of blood which will be used from the blood sample collected for routine preoperative tests (surgical profile) before their planned surgery or for disease evaluation.

3. Small tissue samples (from ovary) will be taken from the tissue which is surgically excised as a part of treatment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: November 15, 2026
• Est. primary completion date: November 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• All the subjects would be of Indian origin (controls ~100, cases ~100). They would be in their reproductive age (18-45 yrs). Rotterdam consensus would be used to diagnose PCOS and cases will be selected based on it.

Criteria for the diagnosis of PCOS would include oligo-ovulation cycles longer than 35 days or less than 26 days, elevated free testosterone levels (0.5 ng/dl; the cutof level for free testosterone level was the mean±2 SD according to normal levels in controls), oligomenorrhea or amenorrhea.

A Ferriman-Gallwey (FG) score of=7 would be taken as indicator for the presence of hirsutism. In accordance with the above criteria, polycystic ovary morphology would be determined by transvaginal ultrasonography, which defines PCOS as the presence of 12 or more small (2-9 mm) follicles in each ovary.

Control subjects would have no signs of menstrual dysfunction and their androgen levels should be within the normal range, with normal glucose tolerance, and no family history of hirsutism, type 2 diabetes mellitus, and infertility.

Exclusion Criteria:

• Women with other causes of hyperandrogenism such as hyperprolactinemia, androgen-secreting tumors, Cushing syndrome and nonclassic congenital hyperplasia would be excluded from this study.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Procedure:
• laparoscopy / laparotomy
We will take both blood and ovarian tissue samples used to diagnosis. We will take approximately 3 ml of blood which will be used from the blood sample collected for routine preoperative tests (surgical profile) before their planned surgery or for disease evaluation. Small tissue samples (from ovary) will be taken from the tissue which is surgically excised as a part of treatment.

Other:
• NO INTERVENTION
.We will take both blood and ovarian tissue samples used to diagnosis. 2.We will take approximately 3 ml of blood which will be used from the blood sample collected for routine preoperative tests (surgical profile) before their planned surgery or for disease evaluation. 3. Small tissue samples (from ovary) will be taken from the tissue which is surgically excised as a part of treatment.

Locations

Country	Name	City	State
India	Dr. Shraddha Ramchandani	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the Analysis of DNA methyl transferases	DNA will be extracted as per the protocol followed routinely in our lab from blood and ovarian tissues.	3 YEARS
Primary	Evaluate the Analysis of differential mRNA and protein expression of epigenetic markers in ovarian tissues	Total RNA from ovarian tissue will be extracted using TRIzol reagent according to the manufacturer's instructions (Invitrogen Life Technologies) and reverse transcribed in the presence of random hexamers. Quantitative real-time PCR reactions will be carried out in an ABI 7000 Thermal Cycler (Applied Biosystems) to analyse the expression of epigenetic markers including the androgen regulated miRNAs and their downstream targets.	3 YEARS
Secondary	understand miRNA regulated epigenetic mechanisms	The present study would investigate the expression pattern of DNMTs, HDACs, miRNAs and their downstream targets in Ovarian tissues (samples of normal adult ovaries and polycystic ovaries) by western blot and immunohistochemical analysis (IHC).	3 YEARS